TB/HIV ResearchApproaches and Challenges
Naomi Bock, MD
Global AIDS Program
Centers for Disease Control and Prevention
February 14, 2005
There is a clear complimentarity and inter-relationship between monitoring and evaluation (M&E), some specific surveillance activities and operational research. All derive “strategic information”, new knowledge and data that will make up the evidence base on ART delivery in resource-limited settings.
Approaches (2)
Western Europe520 000 – 680 520 000 – 680
000000North Africa & Middle
East470 000 – 730 000470 000 – 730 000
Sub-Saharan Africa25.0 – 28.2 25.0 – 28.2
millionmillion
Eastern Europe & Central Asia1.2 – 1.8 1.2 – 1.8 millionmillion
South & South-East Asia
4.6 – 8.2 4.6 – 8.2 millionmillion
Australia & New Zealand
12 000 – 18 00012 000 – 18 000
North America790 000 – 1.2 790 000 – 1.2
millionmillionCaribbean350 000 – 590 000350 000 – 590 000
Latin America1.3 – 1.9 million1.3 – 1.9 million
East Asia & Pacific700 000 – 1.3 700 000 – 1.3
millionmillion
NNRTI Response StudyObservational Study of
Treatment Effectiveness and Resistance Patterns among Women Initiating Treatment with Non-nucleoside Reverse-transcriptase Inhibitor-based HAART after Previous Single
Dose Nevirapine (SD NVP) in Pregnancy
Welcome to the NNRTI Response Study Website.
The Epidemiology Branch of the Division of HIV/AIDS Prevention and the Care and Treatment Branch of the Global AIDS Program (GAP), U.S. Centers for Disease Control and Prevention in Atlanta are jointly coordinating this study to examine the response to highly active antiretroviral therapy (HAART) that includes nevirapine (NVP) among women who have been exposed to prior single-dose (SD) NVP as compared to those who have not. This is a prospective observational study consistent with the goal to conduct clinically applicable operational research that is expected to directly inform program implementation.
This study will be conducted in at least 2 sites, including Zambia and in Thailand, under the direction of the Principal Investigators listed. The sites where the study will be conducted are providing non-nucleoside reverse transcriptase inhibitors (NNRTI)-based HAART to persons attending their clinics. Some of the women attending these clinics have received SD-NVP for PMTCT in the past and others have not. This study intends to use the opportunity that has been presented at the early stage of a period of rapid expansion of antiretroviral therapy in resource-constrained settings to generate data to address the important question of response to NNRTI-based HAART therapy among women who have received SD-NVP for PMTCT as compared to women who have not.
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International Union Against Tuberculosisand Lung Disease
Study AReport of a Controlled Clinical Trial of
Two Durations of Chemotherapy for the Treatment of Tuberculosis
Amina Jindani, Andrew Nunn, Donald EnarsonFor the Clinical Trials Programme Investigators
†
The TB Trials Consortium (TBTC)
• Funded since 1998 by the Division of TB Elimination, CDC
• 28 clinical sites worldwide
• Links to local TB control programs
• TBTC Mission: “… to conduct TBTC Mission: “… to conduct programmatically programmatically relevantrelevant clinical, laboratory, and epidemiologic clinical, laboratory, and epidemiologic research concerning the diagnosis, clinical research concerning the diagnosis, clinical management, and prevention of tuberculosis management, and prevention of tuberculosis infection and disease.”infection and disease.”
28 clinical sites worldwide
CDC Administrative, Statistical, and Data Management Center
Rio de Janeiro
Barcelona
Kampala
Durban
Database on global MDR-TB research activities
Background
Currently, there is a lack of evidence available to develop policy recommendations for the management of multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income settings. As a result, WHO and partners developed the DOTS-Plus strategy which is currently being tested through pilot projects and operational research activities. In order to stimulate global MDR-TB research activities the Stop TB Working Group on DOTS-Plus for MDR-TB has developed a prioritised research agenda for DOTS-Plus.
-A prioritised research agenda for DOTS-Plus for multidrug-resistant -tuberculosis (MDR-TB) [pdf 51kb]The Stop TB Working Group on DOTS-Plus for MDR-TB. International -Journal of Tuberculosis and Lung Disease 2003, 7(5): 410-414.
In addition, a database on global MDR-TB research activities has been created with the following purpose:
World Health Organization
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http://www.who.int/tb_search/
DOTS Plus and the Green Light Committee
WHAT IS DOTS-PLUS?
Based upon DOTS, DOTS-Plus is a comprehensive management strategy under development and testing that includes the five tenets of the DOTS strategy. DOTS-Plus takes into account specific issues (such as the use of second-line anti-TB drugs) that need to be addressed in areas where there is high prevalence of MDR-TB. Thus, DOTS-Plus works as a supplement to the standard DOTS strategy. By definition, it is impossible to conduct DOTS-Plus in an area without having an effective DOTS-based TB control programme in place.. ..
WHAT IS THE GREEN LIGHT COMMITTEE?
World Health Organization
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http://www.who.int/tb/dots/dotsplus/management/en/
Local Involvement
• National / District / Local programs involved in planning as well as implementation
• Strengthen TB programs
• Avoid redirecting scarce resources
• Include the community of people with TB and HIV
Local Involvement
• National / District / Local programs involved in planning as well as implementation
• Strengthen TB programs• Avoid redirecting scarce resources• Include the community of people with TB
and HIV• HIV programs involved in planning,
implementation, evaluation, policy
Declaration of Helsinki
“Concern for the interests of the subject must always prevail over the interests of science and society.”
1975 revision
Tuskegee Study of Untreated Syphilis
• Conducted – To study the natural history of untreated
latent syphilis– By US Public Health Service, with
support from the Milbank Memorial Fund
– Beginning in 1932
Tuskegee Syphilis Ad Hoc Panel, 1973
• No informed consent
• Vulnerable population
• Undue inducements - burial costs
• Participants not informed when penicillin therapy became available in the 1950s
• Participants systematically blocked from receiving treatment
In 1997, surviving participants of the Tuskegee Syphilis Study and their families gathered at the White House to witness the President's apology on behalf of the United States government
Proposed Roles of WHO
• Database of research studies
• GLC approach to those programs interested in participating in research– Program strengthening with partners– DTBE/CDC and Union operational research
courses
Proposed Roles of WHO (2)
• Facilitating human resource expansion – Identifying training grants which fund masters
or doctoral students for in-country research– Stimulating donors to create more such
programs
• “Club” of National/District/local programs participating in research at program level, including multi-centre research